Підходи до проведення досліджень полімерних матеріалів первинної упаковки на етапі фармацевтичної розробки генеричних лікарських засобів

Abstract

The article analyzes approaches to research of polymer materials in primary packaging stage pharmaceutical development of generic drugs. Studying the possibility of using primary packaging based on polyvinyl chloride (PVC) in the form of a blister for cancer dmg based of the temozolomide in solid oral dosage form shows that both packaging materials and quality parameters of the finished product indicate the suitability of that package. Established that the packaging material based on PVC has not changed its general properties, identity and limits of vinyl chloride and tin in contact with the drug on the basis of the temozolomide. It is shown that the dmg corresponds to the permissible limits in all parameters of the study of stability obtained in controlling a dmg based on the specification temozolomide shelf life. Recommended control developed quality indicators in primary packaging specifications at incoming inspection packaging and blister tightness testing and conformity marking - in the production process.